DETAILED ACTION
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 .
Applicant’s response (amendments, arguments) filed after-final (11/14/24) are acknowledged per the advisory action as well as the RCE filed thereafter on 12/13/24 (which crossed in the mail after the Advisory Action had been processed but not yet mailed). As no new amendments have been filed with the RCE, the issue of new matter raised by the previous amendment (616.3 Da) and discussed in the advisory action is applied below alongside the maintaining of the written description on the grounds of record.
As previously noted relevant to claim 21, the process steps/elements of the product by process claim do not fill the gap as to the still missing structural elements (actual sequence) of the peptide derivative(s) (products) scope claimed.
The examiner remains open to further interview.
Election/Restrictions - Maintained
Applicant’s election without traverse of Group I, claims 1-7 and 17-20, as drawn to the species of any fragment of an O-PC of PC, in the reply filed on 6/16/23 is acknowledged.
See also attached Interview Summary.
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description,
Modified (New Matter) & Maintained
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 3-7, 17, 19-21 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
Here, Komorowskietal., "Enhanced Antioxidant Activity of Phycocyanin Oligopeptides," Current Developments in Nutrition, 2021;5(2):p.336, is deemed representative of the art.
However, in this case, there are no structures or sequences found as to that elected or claimed: “fragments” of the O-CP’s from PC’s as elected/claimed. As such, no reasonable search of the claimed invention is possible without more guidance as to what minimal amino acids/fragments must be present (beyond just e.g. Dalton weights).
New Matter (FP 07-31-01): 616.3 Da. Regarding the latter, applicant has now added the limitation 616.3 Da for which no support is found in the specification as originally filed, per the Advisory Action: While the post-filing evidentiary test data presented by way of affidavit may have identified 616.3 Da as an element, such does not supplant the specification as originally filed and therefore cannot itself constitute a permitted new claim limitation. Such evidence may support a Da value slightly above 616.3 Da but such was not amended into the claims nor identified, but may be considered for the future. Thus, 616.3 Da constitutes new matter and is rejected equally as lacking possession/support with the specification as filed.
In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111; clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry,whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of Ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed chemical structure of the encompassed variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovinesequence.
As previously stated as to claim 21, such contains the same ‘product’ scope – the subject matter class claimed. The process steps/elements of the product by process claim do not fill the gap as to the still missing structural elements (actual sequence) of the peptide derivative(s) (products) scope claimed. Thus, claim 21 is equally rejected on the same grounds.
Therefore, the full breadth of the claims are not presently deemed to have been in Applicant’s ‘possession’ and found to meet the written description provision of 35 U.S.C. §112.
Response to Amendments (New Matter, 616.3 Da)/Arguments
Applicant’s amendments and arguments have been fully considered, but not found persuasive, based on the New Matter issues (616.3 Da) in the last claim amendment and for the previous reasons of record: The rejection is maintained as no new substantive amendments have been carried out which provided the actual peptide sequence structure of any one or more oligochromopeptide derivatives of phycocyanin and thus a lack of possession remains as to any such peptide derivative product (the subject matter class claimed).
Further, there was no post-filing evidence submitted as to structure/sequence of the peptide product subject matter claimed, which may be compared to any future representative examples of the derivatives claimed should the sequence thereof be fully identified, that might support the molecular weight and optical absorbance maximum range claimed in order to determine if sufficient representative examples may have been deduced to support that applicant was or was not in possession of the product scope as currently claimed and only directed to ranges tied to molecular weight and optical absorbance.
Previously, discussion was also held as to the following evidentiary reference (*see below; not needed to be relied upon) to Ducet et al. published in 1994 by the NIH as teaching the full amino acid sequence of the claimed wild-type peptide phycocyanin (334 amino acids total bearing a 182-amino acid alpha chain and a 162-amino acid beta chain). If not also disclosed within Ducet, PHOSITA could determine the two (2) instantly claimed elements of: 1) molecular weight and 2) optical absorbance maximum by deduction, if needed, in order that such may be compared against any ultimately sequenced derivative here of which possession has still not been evidence (not yet sequenced as filed or via any post-filing evidence). Until such be shown, the written description rejection has been maintained as only reciting a product by process for which certain method steps have been claimed, but without any sequence data for which possession of any actual peptide sequence could be deduced.
It was further noted that the DNA caselaw upon which the arguments for "possession" were based are not found persuasive as not being directed to peptide/protein products - the claimed subject matter here - not DNA.
*See Ducet et al. The complete amino acid sequence of R-phycocyanin-I alpha and beta subunits from the red alga Porphyridium cruentum. Structural and phylogenetic relationships of the phycocyanins within the phycobiliprotein families. Eur J Biochem . 1994 Apr 1;221(1):563-80. https://pubmed.ncbi.nlm.nih.gov/8168545/
The aforementioned amendments and arguments thereto do not provide a sufficient structure upon which the claimed “oligochromopeptide(s)” may be ‘reasonably’ searched within the acceptable USPTO search databases for peptides, oligopeptides, polypeptides, and proteins (e.g. the USPTO’s 8 internal sequence databases via SEQ ID NO: identified within a computer readable form (CRF) or chemical structure via i.e. STN). The USPTO does not have search database that permits a ‘reasonable’ search of any peptides, oligopeptides, polypeptides, and proteins ‘simply’ based on the ‘weight(s)’ and/or ‘optical absorption’ thereof – which then has the capacity to ‘convert’ such to an actual sequence(s)/chemical structure(s) thereto – in order that THAT sequence(s)/structure(s) can THEN be searched against the relevant USPTO’s 8 internal sequence database(s) and/or chemical structure via i.e. STN.
Further, the USPTO is not a lab, having insufficient resources to take ‘weights’ and ‘optical absorption’ and attempt to determine the ‘actual’ oligochromopeptide sequence(s)/chemical structure(s) that may fall within those parameters. However, applicant remains welcome to carry out the remaining work left to identify the ‘actual’ oligochromopeptide sequence(s)/chemical structure(s) that may fall within those parameters and may submit such as post-filing evidence via Declaration. Upon verification that the submitted sequence/structure corresponds to the parameters currently claimed, the Office will then be able to carry out a ‘reasonable’ search of the ‘actual’ intended oligochromopeptide sequence/structure claimed. As stated above, based on the relevant case law:
The skilled artisan cannot envision the detailed chemical structure of the encompassed variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required.
See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Thus, there remains a lack of ‘possession’ as to the ‘actual’ oligochromopeptide sequence/chemical structure as currently claimed, absent a Declaration thereto with evidence tying the former to the presently claim weight(s)/maximum optical absorption range. This lack of possession and written description as to the sequence(s)/chemical structure(s) thereto also does not permit a ‘reasonable’ search of the ‘actual’, intended oligochromopeptide sequence/structure claimed.
Note I: All remaining claim language beyond that discussed above within instant product claims is directed to either inherent properties (e.g. “. . . being acid labile . . . ”) or intended use (“. . . for treating, preventing, or ameliorating . . .”); adding no further elements to the products.
Note II: A product is a product. Claims 17, 19 and 20 remain substantively duplicates of claims 1, 4 and 7, absent evidence to the contrary and should be cancelled without prejudice in the next response - unless additional elements are added to the former v. the latter. Were allowable subject matter found the former would have to be cancelled without prejudice without further limitations added thereto.
As previously recited and still relevant, upon closer review, while the examiner had hoped that a ‘reasonable’ search of the invention as claimed could be carried out, such is still not possible – as detailed below. The examiner remains open to further interview if desired by applicant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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