Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Applicant's election with traverse of claims 20-21 (group III) in the reply filed on 11/03/2025 is acknowledged. The traversal is on the ground(s) that the European examiner did not require a lack of unity between the claims and did not believe that there was a separate invention. This is not found persuasive because as provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 15, 17-19, and 22, drawn to a pharmaceutical composition for use in the prevention or treatment of a blood vessel disease.
Group II, claim 16, drawn to a pharmaceutical composition for use in the prevention or treatment of a disease.
Group III, claims 20-21, drawn to a medical device.
Group IV, claims 23-25, drawn to a pharmaceutical composition or medical device.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-IV lack unity of invention because even though the inventions of these groups require the technical feature of comprising an extract of Arthrospira or spirulina and/or phycobiliproteins, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US PGPUB 20060024328 A1 (Pasco, 2006; as submitted on IDS of 03/21/2023). Pasco teaches a pharmaceutical composition (see paragraph 0021) comprising the extract of a microalgae, such as spirulina species (see paragraph 0001, abstract).
The requirement is still deemed proper and is therefore made FINAL. Claims 20-21 will be examined on the merits. Claims 15-19 and 22-25 are withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/21/2023 has been considered here.
Claim Objections
Claim 20 is objected to because of the following informalities: The claim reads “Arthrospira” which should read “Arthrospira”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 depends from withdrawn claim 22. The metes and bounds of the claim would not be understood by one with ordinary skill in the art, thus it is indefinite. For purposes of search and consideration, the claim is read as being dependent from claim 20.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are drawn to a medical device “for use” in a method, which is not one of the statutory categories. Applicant is advised to amend the use claim of 21 to be in standard US claim practice, or to cancel said claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20100254900 A1 (Campbell, 2010).
In regards to claim 20, Campbell teaches a polymer composition that is useful in biological systems for stents and implants (see Campbell, abstract). The polymer composition is taught to comprise phycobiliproteins (see Campbell, paragraph 0119). The polymer composition is taught to be in the form of a hydrogel, which is dried onto a structure or surface, creating a film coating on the structure or surface (see Campbell, paragraphs 0104-0108). It is also taught that the composition is used to fabricate a coating on medical devices such as stents, heart valves, dental implants, among others (see Campbell, paragraph 0163).
In regards to claim 21, as the teachings of Campbell would yield an identical medical device as instantly claimed, the properties, such as being used to treat or prevent the diseases listed in claim 21, would be present since physical properties are not separable from the products themselves. It is also important to note that claim 21 claims a future intended use (for use in the prevention or treatment of a disease), however the future intended use of a product is not considered to contribute to the overall patentability of the instant invention, particularly when the product itself is claimed and that same product is taught in the prior art. Despite this, it is noted that Campbell teaches that the composition is used to treat restenosis (see Campbell, paragraph 0159).
Campbell does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Campbell with a reasonable expectation of success to obtain the medical device of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the medical device of the instant claims with predictable results.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611