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 .
Election/Restrictions
1. Applicant's election with traverse of Group I in the reply filed on July 28, 2026 is acknowledged. The traversal is on the ground(s) that, “[B]ecause the claims of all of Groups I-III describe a syringe with an elastomeric needle shield having a low zinc leaching capacity and an antibody solution with particular characteristics as defined in independent claims 1, 10, 13 and 15, applicant submits that the claims share a common technical feature and have unity of invention.” This is not found persuasive for the following reasons. It is noted that claim 1 has been amended to read on the invention of Group III, a prefilled syringe. Thus, the first claimed product, a syringe and a method of producing the syringe form a single general inventive concept. The methods of suppressing a viscosity increase and/or needle clogging of Group II do not read on the same inventive concept and therefore represent a patentably different invention.
The requirement is still deemed proper and is therefore made FINAL.
2. Claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 28, 2026.
3. Claims 1-9 and 13-15 are under examination.
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.
4. Claims 1-9 and 13-15 are 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.
5. The term “low” in claims 1 and 2 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Providing a point of reference or comparison within the claims would obviate this ground of rejection.
6. Claim 6 recites a modal verb “can,” which renders the claimed subject matter indefinite because the claim includes occurrences and possibilities (those encompassed by "can"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
7. Claims 7-8 are vague and ambiguous for describing what appears steps within the claimed product, see “capacity is evaluated.” A skilled artisan would not be able to distinguish the product of claim 1 from the product of dependent claims 7 and 8 based on the presence of limitation “evaluated.” Amending the claims to recite what the product is rather than how it has been evaluated would obviate this ground of rejection.
8. Claim 13 is indefinite in recitation of “suitable for,” which appears subjective and therefore prone to multiple interpretation.
MPEP 2173.05(b) IV, Subjective terms, states When a subjective term is used in the claim, the examiner should determine whether the specification supplies some objective standard for measuring the scope of the term. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)); see also Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. Cir. 2014) (holding the claim phrase "unobtrusive manner" indefinite because the specification did not "provide a reasonably clear and exclusive definition, leaving the facially subjective claim language without an objective boundary").
9. Similar to claims 7-8 above, see section 7, claim 14 is indefinite for reciting limitation “capacity is evaluated” while being drawn to a product.
10. Claims 3-5 and 9 are indefinite for being dependent from indefinite claim(s).
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
11. Claims 1-9 and 13-15 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-9 and 13-15 specifically require possession of the antibodies that have a total number of histidine, aspartic acid and glutamic acid present in a CDR region of 6 or more, those residues that are adjusted to each other within three residues in a CDR region, the antibodies with substitution of at least one amino acid with histidine or an insertion of at least one histidine, wherein the antibodies bind to an antigen depending on pH and having specific value of KD. The claims do not require that these antibodies possess any clearly disclosed structure, conserved structure or other disclosed distinguishing feature. Thus, the claims are drawn to a genus of antibodies that is defined only by reference to the preferred substitutions. However, disclosing a partial structure does not satisfy the written description requirement and evidence of procession for an antibody.
Section 112 states that “[t]he specification shall contain a written description of the invention … in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same . . . .” This requirement ensures “that the inventor actually invented the invention claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). To show invention, a patentee must convey in its disclosure that it “had possession of the claimed subject matter as of the filing date.” Id. at 1350. Demonstrating possession “requires a precise definition” of the invention. Id. To provide this “precise definition” for a claim to a genus, a patentee must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id.
MPEP 2163, II A3(a)(ii) states,
For each claim drawn to a genus:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the gen[us]”. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
In the instant case, the recitation of an antibody wherein some of the amino acids of the variable region have been substituted with histidine represents a partial structure. The specification fails to provide an exemplified number of histidine substitutions in the CDR region for any antibody. There is no description of antibodies that have a total number of histidine, aspartic acid and glutamic acid present in a CDR region of 6 or more, those residues that are adjusted to each other within three residues in a CDR region, the antibodies with substitution of at least one amino acid with histidine or an insertion of at least one histidine, wherein the antibodies retain their intended function, such as being suitable for clinical administration. Further, there is no art-recognized correlation between any structure and the activity of antigen binding, based on which those of skill in the art could predict which histidine substitutions could be made without losing antibody binding.
Next, with respect to antibodies, an important consideration is that structure is not necessarily a reliable indicator of function. In the instant case, there is no disclosure relating similarity of structure to conservation of function. Importantly, the "at least one amino acid" histidine substitution is in the "variable region". However, the state of the art is that even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the
CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff et al
(Proc. Natl. Acad. Sci. USA, 79(6): 1979-1983, March 1982). Rudikoff teaches that the
alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of antibodies, 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 bovine sequence.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Conclusion
12. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
August 5, 2026
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