DETAILED ACTION Claims 1-8 are pending and being examined on the merits in this office 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. Specification Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See specification at pp. 15 and 41. Claim Objections Claim s 1-8 are objected to because of the following informalities: Claim 1 should be amended to recite “to the human in need thereof ”. Claims 2-8 should be amended to recite “ claim Claim 1, wherein in which ”. Appropriate correction is required. Claim Rejections - 35 USC § 112 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. Claims 1- 8 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated: “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated: “A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618. For written description, the analysis considers (a) Actual reduction to practice, (b) Disclosure of drawing or structural chemical formulas, (c) Sufficient relevant identifying characteristic in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed and (d) Representative number of examples. In the instant case, the claims are drawn to a method of stimulating survival or recovery of tissue damaged by a cerebrovascular event in a human comprising administering a therapeutically effective amount of Pregnancy specific glycoprotein 1 (PSG1) to the human. Claim 8 is drawn to the method of claim 1, in which the PSG1 is administered to the subject within 6 hours of the cerebrovascular event. The specification states at p. 10, ll. 21-34: As used herein, the term “cerebrovascular event” or “CVA” refers to a cerebral ischemia or haemorrhage in a subject that causes a neurologic symptom or symptom complex. It is also commonly referred to as a “stroke”. The main clinical features are sudden or subacute onset and (except for subarachnoid haemorrhage) focal neurologic deficit. … Cerebrovascular diseases are subdivided into ischemic events and cerebral haemorrhages, with many etiologies for each. Ischaemic events are further classified according to whether symptoms occurred in the carotid or vertebrobasilar distribution and by the duration of symptoms. Transient ischaemic attacks (TIAs) seldom last more than a few minutes and never more than 24 hours. In ischaemic stroke, the neurologic deficit has been present more than 24 hours and may be progressive, stable, or resolving. The specification states: [T]he PSG1 is administered to the subject within 72, 48, 24, preferably 18, more preferably 12, more preferably 6, more preferably 4, and ideally within 2 hours of the cerebrovascular event (p 3, ll. 17-19). The specification states at p. 40, ll. 23-31: As a non-limiting example, treatment of disease in humans or animals can be provided by administration of a daily dosage of protein of the invention in an amount of about 0.1-100 mg/kg, such as 0.5, 0.9, 1.0, 1.1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 40, 45, 50, 60, 70, 80, 90 or 100 mg/kg, per day, on at least one of day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40, or alternatively, at least one of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20, or any combination thereof, using single or divided doses of every about 24, 12, 8, 6, 4, or 2 hours, or any combination thereof. Examiner expressly notes that the instant claims are not limited to any particular time line between the occurrence of the cerebrovascular event and initiation of administering a therapeutically effective amount of PSG1 to the human . Specifically, the claims encompass variable time frames of administering PSG1, e.g., within hours of the cerebrovascular event, to as long as 50 years after the cerebrovascular event. Examiner acknowledges that claim 8 recites administ ration of PSG1 within 6 hours of the cerebrovascular event . (a) Actual reduction to practice/ (b) disclosure of drawing or structural chemical formulas: The specification reduced to practice only two examples- Example 2 a cell assay, and Example 3- a mouse stroke model. In Example 2, human microglia cells (C20) were incubated with recombinant PSG1 for 5 hours. In example 3, a mouse stroke model- mice were treated with either phosphate buffered saline (PBS) or 100 ug PSG1 within 1 hour of the stroke . Thus, specification is limited to a single animal model in which mice were treated with PSG1 within 1 hour of the cerebrovascular event . (c) Sufficient relevant identifying characteristic in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed: and (d) Representative number of examples: The invention involves an unlimited dosing regimen/schedule for administering PSG1 following a cerebrovascular event. However, the specification only provides guidance for a single dosing timeframe of 1 hour following a cerebrovascular event. The specification did not disclose any examples in which administration of PSG1 is initiated at a later timepoint following a cerebrovascular event . It is unclear from the specification and examples as to whether or not therapeutic efficacy [stimulating survival or recovery of tissue damaged by the cerebrovascular event ] is achieved with administration of PSG1 occurs beyond 1 hour after the cerebrovascular event . As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It must not be forgotten that the MPEP states that if a biomolecule is described only by a functional characteristic and/or a functional/structural characteristic without any disclosed correlation between function and structure of the biomolecule beyond the examples presented, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.” MPEP 2163. Here, though the claims encompass administering PGS1 many years after the initial cerebrovascular event for stimulating survival or recovery of tissue damaged by a cerebrovascular event, it is unclear if such a long delay in administering PGS1 would yield therapeutic results. The instant specification is limited to reducing to practice administering PSG1 within 1 hour following cerebrovascular event. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). The skilled artisan cannot extrapolate to the myriad of dosing schedules that fall within the instant claim scope based on a single timepoint of treatment at 1 hour after the cerebrovascular event, as reduced to practice. Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. 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 6-8 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. Claims 6-8 recite the limitation "the subject". There is insufficient antecedent basis for this limitation in the claim. Independent claim 1 recites a human, not a subject. 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. Claim(s) 1 and 3- 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deng ( 2006 / 0063162 - cited in IDS filed 10/12/2023). Deng teaches methods and compositions for the diagnosis and treatment of inflammation, in particular, vascular pathologies, comprising pregnancy specific glycoproteins (e.g., abstract, paras. [0009]-[0015] ). PSG polypeptide includes PSG1 (para [0017]). Preferred modulators increase PSG activity or expression in vascular tissue (para. [0084]). Vascular pathologies include, but are not limited to, vascular inflammation, endothelial dysfunction, thrombosis, atherosclerosis, coronary artery disease, tachycardia, hypotension, hypertension, cerebrovascular disease , carotid artery bruits, focal neurological deficits, peripheral vascular disease, decreased peripheral pulses, peripheral arterial bruits, pallor, peripheral cyanosis, gangrene, ulceration, abdominal aortic aneurysm, pulsatile abdominal mass, peripheral embolism, circulatory collapse, stroke , and atheroembolism (e.g., para s [0004], [0015], [0034]- [0039]). Deng teaches the term “therapeutically effective amount” refers to that amount being administered which will relieve to some extent one or more of the symptoms of the disorder being treated. In reference to vascular pathologies or conditions, a therapeutically effective amount refers to that amount which has the effect of (1) reducing inflammation, plaque formation, or monocyte adhesion, (2) inhibiting (that is, slowing to some extent, preferably stopping) inflammation, plaque formation, or monocyte adhesion (3) relieving to some extent (or, preferably, eliminating) one or more symptoms associated with vascular inflammation including but not limited to atherosclerosis and other vascular inflammation pathologies (para [0020]). “Treating” or “treatment” of a disease includes preventing the disease from occurring in an animal that may be predisposed to the disease but does not yet experience or exhibit symptoms of the disease (prophylactic treatment), inhibiting the disease (slowing or arresting its development), providing relief from the symptoms or side-effects of the disease (including palliative treatment), and relieving the disease (causing regression of the disease) (para [0025]). Deng does not explicitly disclose a method to “stimulate survival or recovery of tissue damaged by a cerebrovascular event”. It would have been obvious to one of ordinary skill in the art to administer an effective amount of PSG1 to a human to stimulate survival or recovery of tissue damaged by a cerebrovascular event. Deng explicitly teaches that vascular pathologies include cerebrovascular disease and stroke. Treatment included relief from the symptoms or side-effects of the disease (including palliative treatment), and relieving the disease (causing regression of the disease). The skilled artisan would have recognized from the teachings of Deng that the treatment of a cerebrovascular event, e.g., stroke, would have encompassed stimulating survival or recovery of tissue damaged by a stroke . The skilled artisan would have had a reasonable expectation of success because Deng taught methods to monitor and assess therapeutic treatment. Accordingly, claim 1 is rendered obvious. Regarding claims 3 and 4, De n g teach that cerebrovascular disease includes a stroke. Thus treatment of the recited forms of stroke, acute ischemic stroke and hemorrhagic stroke, are deemed to be obvious. Regarding claim 5, Deng teach the cerebrovascular event can be a transient cerebral ischemia (i.e. a “small stroke”, if a brain vessel is involved) (e.g., para. [0039]). Regarding claim 6, Deng teach administration by intravenous injection (e.g., para. [0103]). Accordingly, claims 1 and 3-6 are obvious in view the teachings of Deng. Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969). Conclusion No claims allowed. Claims 1-8 are pending and are rejected. 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