DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Upon reconsideration, the finality of the last Office is withdrawn, and Applicant’s amendment filed 9/25/25 is entered.
Claims 90-91, 108-117 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 89 and 118-124 are under examination.
The previous grounds of rejection are withdrawn in view of Applicant’s claim amendments and terminal disclaimer filed 9/5/25.
The following are new grounds of rejection.
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.
Claims 118-119 and 123-124 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 118 recites the limitation "the immune response" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 123 recites the limitation "the polypeptide of SEQ ID NO: 7 or SEQ ID NO: 14" in line 3. The claim depends from claim 89 which is directed to a polypeptide comprising “an amino acid sequence” selected from the group consisting of SEQ ID NO: 7 and 14. There is insufficient antecedent basis for “the polypeptide of SEQ ID NO: 7 or SEQ ID NO: 14” in claim 123 or in claim 89, from which it depends. Therefore, the claim is unclear and indefinite. For example, a polypeptide comprising SEQ ID NO: 7, as recited in claim 89, would include a larger polypeptide having SEQ ID NO: 7 as a subsequence. Does the claim 123 require that the further 1 to 12 amino acids are at the N or C terminus of “the amino acid sequence” of SEQ ID NO: 7, or could they be at the end of the (larger) polypeptide comprising SEQ ID NO: 7.
Claim 124 recites the limitation "the polypeptide of SEQ ID NO: 7 or SEQ ID NO: 14" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 89 and 118-124 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) a polypeptide comprising SEQ ID NO: 14. This judicial exception is not integrated into a practical application because said polypeptide is a product of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including “physical phenomena,” “scientific principles”, “natural laws,” and “products of nature.” Product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g.,Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (“Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g.,In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart. See MPEP 2106.04(b).
The instant claims are directed to a polypeptide comprising SEQ ID NO: 14. However, said polypeptide reads on a product of nature. See GenBank ABE97323 and Andersen, 2006, which describe a naturally occurring antibody heavy chain variable region isolated from human sera of women who were exposed to alloantigen naturally during the course of pregnancy. Said heavy chain variable region comprises SEQ ID NO: 14 of the instant application (see residues 68-94). Regarding the recitation of an “isolated” polypeptide or peptide, the specification further discloses that a polypeptide is said to be isolated when it is substantially free of cellular material, and that a polypeptide comprising, consisting essentially of, or consisting of SEQ ID NO: 1-124 can be joined to, linked to, or inserted into another heterologous polypeptide and still be “isolated”. Thus, the polypeptides of the prior art which comprise SEQ ID NO: 14 are within the scope of an “isolated” peptide or an isolated regulatory T cell epitope. Furthermore, even if the claims were directed to a peptide consisting of SEQ ID NO: 14, this would still be a product of nature, since the fact that a peptide is isolated from a larger peptide or protein (e.g. chemical bonds on either end of the peptide have been “broken”) does not rise to the level of a marked difference, because there is no change to the sequence of the peptide. Furthermore, the limitation of a composition or pharmaceutical composition, recited at a high level of generality amounts to nothing more than field of use or insignificant extra-solution activity. Therefore, the claim does not recite any additional limitations or elements that amount to significantly more than the judicial exception.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 89, 123 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GenBank: ABE97323.1, 2016.
The GenBank entry teaches a VH polypeptide from an anti-Rh antibody comprising SEQ ID NO: 14 (see residues 68-94). Said polypeptide comprises at least one amino acid on the N and C terminus, which meets the limitation of claim 123 (i.e. the claim is directed to a polypeptide comprising said 1 amino acid, which is open to unrecited elements such as additional amino acids).
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.
Claim 89 and 118-124 is/are rejected under 35 U.S.C. 103 as being unpatentable over GenBank: ABE97323.1, 2016, in view of Anderson, 2006.
The teachings of GenBank are described above.
The reference differs from the claimed invention in that it does not explicitly teach a composition or pharmaceutical composition comprising an effective amount of said polypeptide.
Anderson teach cloning anti-Rh antibody Vh and VL polypeptides, and that anti-Rh antibody can be expressed as a panel of antibodies and can be used as pharmaceutical composition for preventing alloimmunization.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to create a pharmaceutical composition comprising an anti-RH antibody panel, as taught by Anderson, including said anti-Rh of Genbank. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because Anderson teach that said RH VH and VL regions can be expressed as a panel of antibodies and can be used as pharmaceutical composition for preventing alloimmunization. Said composition would include additional “antigens” or immune stimulating epitopes that are naturally found within the VH and VL polypeptides. Furthermore the property of suppressing an immune response would be a latent or inherent property of SEQ ID NO: 14.
Regarding the recitation of an “isolated” polypeptide or peptide, the specification further discloses that a polypeptide is said to be isolated when it is substantially free of cellular material, and that a polypeptide comprising, consisting essentially of, or consisting of SEQ ID NO: 1-124 can be joined to, linked to, or inserted into another heterologous polypeptide and still be “isolated”. Thus, the polypeptides of the prior art which comprise SEQ ID NO: 14 are within the scope of an “isolated” peptide or an isolated regulatory T cell epitope.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker, can be reached at telephone number 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644