Understanding Product by Process Claims

Introduction:

Claims of a patent specification are interpreted to define the scope of protection granted to an invention, and hence immense care is exercised while drafting claims. There are various types of claims that can be drafted to protect an invention, and one such type of claim is a “product-by-process” claim. Generally a product claim is used for protecting a product. However, in some cases one may find it difficult to describe a product in a claim, and in such scenarios a product-by-process claim is considered as an option to protect the product. A product-by-process claim attempts to protect the product by describing the process by which the product is manufactured. An example of a product-by-process claim is provided below.

Claim from US4935507:

Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by dissolving 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) in an alcohol, continuing to stir the solution slowly under warming, then cooling the solution to room temperature and allowing the solution to stand.

Novelty and Obviousness:

The approach taken to judge novelty and obviousness of a product-by-process claim is significantly different from the approach adopted to judge novelty and obviousness of other types of claims, such as product claims and process claims.

A product-by-process claim is considered to be novel only if the product mentioned in the preamble is novel. For example, a product-by-process claim claims a product X prepared by a process Y. Product X is known in art, whereas the process Y for manufacturing the product X in new. Even though the process Y is not known in the art, the product-by-process claim will lack novelty because the product X is known in the art.

It is therefore advisable to claim a process for obtaining the product by a process claim, rather than claiming the product using a product-by-process claim.

Infringement of product-by-process claims

Earlier, a product claimed by a product-by-process claim was considered to be infringed even if the product claimed was prepared using a different process. However, at present, a product claimed by a product-by-process claim is considered to be infringed only if the product is obtained by a process claimed but not by a different process.

The earlier approach of determining infringement of a product-by-process claim is evident in Scripps Clinic & Research Foundation v. Genentech, Inc.

Scripps Clinic & Research Foundation v. Genentech, Inc.

Scripps’ patent (RE 32,011) included both product-by-process claim and process claim. The litigation concerns a substance called human Factor VIII:C. Scripps had used chromatographic adsorption technique for obtaining the aforementioned substance. Genentech isolated the same substance as Scripps, although the process used by Genentech was recombinant DNA technique.  

District Court Judgement:

No infringement as the product is obtained by different process.

Federal Circuit judgement:

The Federal Circuit held that Scripps' product-by-process claims were infringed by Genentech's product however made.

In the above case it was set forth that the claims may not be construed one way in order to obtain their allowance and in a contrary way against infringers.

The current approach of determining infringement of a product-by-process claim is evident in Atlantic Thermoplastics Co. Inc. v. Faytex Corp.

Atlantic Thermoplastics Co. Inc. v. Faytex Corp.

The views expressed in Scripps was no longer followed, and a landmark decision was passed in the instant case.

Atlantic had a patent (US4674204) granted for “Shock absorbing innersole and method for preparing same”. Atlantic patent included process claims as well as a product-by-process claim.

Atlantic sued Faytex for infringement of their patent. Faytex however argued stating that they have not manufactured the innersole, and had bought the innersole from two different manufacturers, Surge and Sorbothane. The court found that Surge process includes each limitation of the claim and therefore infringes the patent owned by Atlantic. However, the process used by Sorbothane was found to be different from the process claimed in the product-by-process claim, and therefore did not infringe the product-by-process claim.

In this case, it was set forth that infringement analysis and patentability analysis will be judged based on different criteria. A product claimed by a product-by-process claim is considered to be infringed only if the product is obtained by a process claimed but not by a different process.

Abbott Laboratories v. Sandoz, Inc.

The views expressed in Atlantic Thermoplastics was upheld in Abbott Laboratories v. Sandoz, Inc. bringing to rest the contradictory views in analyzing infringement of product-by-process claims.

Federal Circuit decision:

The court today overturns this expedient for all circumstances, brooking no exception. Acting en banc for the purpose, the court rules that if any process term or descriptive aspect is included in a product claim to aid in distinguishing a new product, the claim cannot be infringed by the identical product unless the same process aspect is used in making the accused product.

Conclusion:

The current approach of analyzing infringement of product-by-process claims has significant implication on patent holders and those attempting to work around existing patents. Patent holders or applicants have to exercise caution while considering a product-by-process claim to protect a product. On the other hand, those attempting to work around existing patents can consider developing a process that is different from a process described in a product-by-process claim, even though the developed process results in the same product claimed in the product-by-process claim.

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Ways to expedite examination of a patent application filed in US

How long does it take to get a patent granted, is one of the most common questions every patent applicant has. The time required to have a patent granted depends on various factors such as the country in which patent application is filed, the technological field of patent application, number of independent and dependent claims in the patent application, so on and so forth. On an average it takes anywhere between 2 to 5 years to have a patent granted.

Considering the quantum of time required to have a patent granted, many applicants wish to accelerate the patent examination process. Patent offices of a few countries have the provision of expediting the patent examination. The United States Patent and Trademark Office (USPTO) is one such patent office that offers the provision of speeding up the patent examination process.

The various options offered by the USPTO that can be availed by an applicant to expedite the examination process are:

  • Prioritized examination
  • Accelerated examination
  • First action interview pilot program
  • Patent prosecution highway
  • Petition to make special

Prioritized examination

Additional fee:

  • Micro entity – USD 1,000
  • Small entity – USD 2,000
  • Non-small entity – USD 4,000

Prioritized examination can be availed at the time of filing original utility and plant patent applications. Prioritized examination for newly filed original utility and plant patent application is also known as “Track One Prioritized examination”. On opting for prioritized examination, the patent application would be granted special status during prosecution of the application.

Eligibility criteria for prioritized examination (Track One):

  • The patent application should be an original non-provisional utility or plant patent applications.
  • Patent application should not contain more than 4 independent claims.
  • Patent application should not contain more than 30 claims in total.
  • Patent application should not contain multiple dependent claims.

Type of application eligible for prioritized examination (Track One):

  • First filing application
  • Continuing application
  • Continuation-in-part
  • Divisional application

Prioritized examination is also extended to Request for Continued Examination (RCE) of an existing utility or plant patent application. Original non-provisional utility and plant patent applications filed under 35 U.S.C. 111, or having entered the national stage under 35 U.S.C. 371, in which a proper request for continued examination (RCE) has been filed, or is concurrently being filed, are eligible for prioritized examination.

Eligibility criteria for prioritized examination for a Request for Continued Examination (RCE):

  • The patent application should be original non-provisional utility or plant patent applications, or national stage application filed under 35 U.S.C. 371
  • Patent application should not contain more than 4 independent claims.
  • Patent application should not contain more than 30 claims in total.
  • Patent application should not contain multiple dependent claims.
  • RCE should be filed with or prior to, prioritized examination request.
  • No previous special status under prioritized examination program should have been granted to the RCE.
  • Request for prioritized examination should be made before mailing of a first office action after filing of RCE.

A maximum limit of 10,000 requests for prioritized examination is granted per fiscal year, and the limit may be subjected to revision. The 10,000 requests include both Track One and prioritized examination for RCE requests. The number of granted prioritized examination requests can be viewed at:

 http://www.uspto.gov/patents/init_events/Track_One.jsp

Final disposition is intended to be provided within 12 months on an average, from the date of granting special status to application availing prioritized examination request.

Accelerated examination

Additional fee:

  • Micro entity – $35
  • Small entity – $70
  • Non-small entity – $140

Accelerated examination is one of the procedures established by the USPTO under which examination of a patent application may be accelerated.  A grantable petition has to be filed by the applicant to make special under the accelerated examination program to advance an application out of turn for examination.

The applicant must meet the following requirements to qualify for the new accelerated examination program:

  • Submit the petition and fee (wherever applicable)
  • File the request with respect to an application filed under 35 USC 111(a)
  • File the application via the EFS or EFS-Web; also all follow-on submissions
  • File a complete application complying with 37 CFR 1.51
  • File 3 or fewer independent claims and no more than 20 claims total
  • File an application for a single invention or agree to elect without traverse a single invention for examination
  • Agree to an interview with the examiner to discuss any outstanding issues arising in the examination process
  • Conduct a pre-examination search
  • Provide an accelerated examination support document

Applications not eligible for accelerated examination program:

  • Plant applications
  • Reissue applications
  • Applications entering national stage from an international applications after compliance with 35 USC § 371
  • Re-examination proceedings
  • Petitions to make special based on applicant’s health or age or under the PPH program

First Action Interview Pilot Program

Additional fee: None

An applicant has to file a request to participate in the First Action Interview (FAI) Pilot program within six months life of the program and at least one day prior to appearance of first office action on the merits of the application in the Patent Application Information Retrieval (PAIR) system.

Some of the benefits of the program for participants:

  • The ability to advance prosecution of the examination
  • Enhanced interaction between the applicant and the examiner
  • Opportunity to resolve patentability issues one-on-one with the examiner at the beginning of the prosecution process
  • The opportunity to facilitate possible early allowance

Note:

  • No additional fee has to be borne by the applicant to avail the First Action Interview Pilot Program
  • Application will not be taken out of turn for this program
  • Eligibility dates of the application for pilot program will be chosen based on the likeliness of the application to come up for examination during the six month window of the pilot program
  • Patent application should not contain more than 3 independent claims
  • Patent application should not contain more than 20 claims in total
  • Patent application should not contain multiple dependent claims
  • The patent application should be directed to single invention.
  • If patent application is identified to have claims directed to more than one invention, the applicant should make an election without traverse.

Pre-Interview communication issued by the examiner includes objections or rejections based on relevant prior art cited. Within 30 days from the date of Pre-Interview communication receipt, the applicant has to schedule an interview with the examiner to discuss the proposed amendments and/or arguments. If an agreement is not drawn at the end of the interview, the examiner will be issuing a first action interview office action which also includes interview summary.

Patent Prosecution Highway

Additional fee: None

The Patent Prosecution Highway (PPH) program was established by the participating intellectual property offices to expedite the examination process of a patent application which has been filed in one or more of the participating patent offices. USPTO is a member of Global Patent Prosecution Highway and IP5 PPH program. No additional fee has to be paid for applications seeking accelerated examination under PPH program. A PPH request has to be submitted via EFS-Web.

Members of Global PPH program:

  • Australia
  • Canada
  • Denmark
  • European Patent Office
  • Finland
  • Hungary
  • Iceland
  • Israel
  • Japan
  • Korea
  • Nordic patent institute
  • Norway
  • People’s Republic of China
  • Portugal
  • Russia
  • Spain
  • Sweden
  • United Kingdom
  • United states

Members of IP5 PPH program:

  • the European Patent Office
  • the Japan Patent Office
  • the Korean Patent Office
  • the State Intellectual Property Office of the People’s Republic of China
  • the United States Patent and Trademark Office

An applicant should have filed a patent application in at least two of the participating intellectual property offices to avail PPH program. The applicant on receiving a final ruling from a first patent office that at least one claim is allowed, file a request under PPH program in the second patent office for speeding up of examination process of corresponding claim(s) in a corresponding patent application that is pending in the second patent office.

Eligibility requirements of applications for accelerated examination under Global PPH program:

  • The application before the Office of Earlier Examination (OEE) and the office of Later Examination (OLE) should have the same earliest date (first filing date or priority date)
  • The OEE has found at least one claim to be allowable. The indication that a claim is allowable will be provided as an explicit statement in any substantive work product from the OEE. The claim(s) determined as novel, inventive and industrially applicable in the PCT work products has/have the meaning of allowable in this document.
  • All claims presented for examination under the GPPH pilot must sufficiently correspond to one or more of the claims found allowable by the OEE.
  • The OLE has not begun substantive examination of the application. However, OLE's may still choose to allow GPPH requests filed after examination of the OLE application has begun depending on the particular circumstances and needs of the OLE and its stakeholders.
  • A request for substantive examination must have been filed at the OLE, either at the time of the GPPH request or previously.

The USPTO in addition with Global PPH and IP5 PPH programs, has PPH agreements with following intellectual property offices:

  • Austria
  • Colombia
  • Czech Republic
  • Germany
  • Mexico
  • Nicaragua
  • Philippines
  • Singapore
  • Taiwan Intellectual Property Office

Petition to make special

Additional fee: None

In furtherance to the above discussed processes for expediting prosecution, a patent application can be made special and patent prosecution can be accelerated on petition to make special based on:

  • The applicant’s age
  • The applicant’s health
  • The invention which enhances the quality of environment
  • The invention that contributes to the development or conservation of energy resources
  • The invention that contributes to counter-terrorism

The applicant’s age:

An applicant of age 65 or above has to file a petition including any supporting documents stating that the applicant is 65 years of age, or more, such as applicant’s statement or a statement issued by a registered practitioner that he or she has evidence that the applicant is 65 years of age or older. No additional fee is required.

The applicant’s health:

An applicant’s application may be made special upon filing a petition along with supporting documents (such as a doctor’s certificate or other medical certificate) stating that the health condition of the applicant is such that he or she might not be available to assist in the prosecution of the application if it were to run its normal course. No additional fee is required.

Environmental quality:

The patent applications for inventions that materially contribute to the enhancement of the environment by restoration and maintenance of the basic life-sustaining elements, i.e., air, water and soil, will be accorded with special status. A petition has to be filed by the applicant for their applications to be accorded with special status. No additional fee is required.

Energy:

All the patent applications for invention which materially contribute to a) the discovery or development of energy resources b) the more efficient utilization and conservation of energy resources will be accorded with special status on filing a petition by the applicant seeking special status. No additional fee is required.

Counter-terrorism:

All the patent applications for invention which materially contribute to counter-terrorism will be accorded with special status on filing a petition by the applicant seeking special status. No additional fee is required.

The types of technology for counter terrorism could include, but are not limited to:

  • Systems for detecting/identifying explosives
  • Aircraft sensors/security systems
  • Vehicular barricades/disabling systems

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US Patent Cases Weekly Update October 21st October 28th, 2014

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Patent Office India Published Patent and Design registration Information October 24th, 2014

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US Patent Cases Weekly Update October 14th October 21st, 2014

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Patent Office India Published Patent and Design registration Information October 17th, 2014

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US Patent Cases Weekly Update October 7th October 14th, 2014

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Patent Office India Published Patent and Design registration Information October 10th, 2014

Indian Patent Office publishes patent information on a weekly basis (on Friday each week). This is a public notification, enabling you to take appropriate action if desired.

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US Patent Cases Weekly Update September 30th October 7th, 2014

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Patent Office India Published Patent and Design registration Information October 3rd, 2014

Indian Patent Office publishes patent information on a weekly basis (on Friday each week). This is a public notification, enabling you to take appropriate action if desired.

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