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 .
Claim Status
Claims 1, 3, and 6-13 are pending. Claims 4-5 were canceled and claims 1 and 6 were amended in the Reply filed 2/06/2026. Claims 3 and 9-13 remain withdrawn. Claims 1 and 6-7 are presently considered.
Election/Restrictions
Applicant's election with traverse of a single subgenus of species of treating Parkinson’s disease by orally administering Prostaglandin B 1 (PGB1) at 0.1 mg/kg to 50 mg/kg, wherein “no additional agent is administered” in the reply filed on 9/09/2025 was previously acknowledged. The traversal was considered but not found persuasive for reasons of record (see, e.g., Action mailed 10/06/2025 at 2-3), and the requirement was deemed proper and made final.
The originally elected species was understood to be a patentably indistinct subgenus of species of treating Parkinson’s disease in patients “in need thereof”, wherein the method comprises the steps of orally administering Prostaglandin B 1 (PGB1) at 0.1 mg/kg to 50 mg/kg, wherein “no additional agent is administered”.
Claims 3 and 9-13 were previously identified as not reading upon the originally elected species for reasons of record (see, e.g., Action mailed 10/06/2025 at 2-3).
Following extensive search and examination, the originally elected species has been deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
Accordingly, claims 1 and 6-7 are rejected in view of the originally elected species and claims that do not read upon the originally elected species are withdrawn.
Claims 3 and 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/09/2025.
Claims 1 and 6-7 are presently considered.
Priority
The priority claim to US Provisional Application 62/537,634, filed 7/27/2017 is acknowledged.
Information Disclosure Statement
No IDS was filed in the Reply filed 2/06/2026.
Claim Interpretation
Amended claim 1 is representative of the pending claim scope and applicable claim interpretations are set forth below. The applicable claim interpretation was previously discussed on record, and that discussion is incorporated into the instant action (see, e.g., Action mailed 10/06/2025 at 4-6).
“Treating” is understood to include inhibiting the disease (i.e., “preventing a worsening of symptoms”) and/or relieving the severity of the disease (i.e., “causing regression of symptoms”) (see, e.g., Spec. filed 7/20/2022 at ¶[00109]).
“Subject” is understood to include humans and animals (see, e.g., Spec. filed 7/20/2022 at ¶¶[00124]-[00127]).
“Subject in need thereof” includes subjects that have a condition or are at risk of developing that condition (see, e.g., Spec. filed 7/20/2022 at ¶¶[00126]-[00127]).
“Administering” is understood to include, but not be limited to oral, parenteral, intravenous, intramuscular, subcutaneous, transdermal, aerosol, pulmonary, cutaneous, topical, injections, and local or systemic delivery (see, e.g., Spec. filed 7/20/2022 at ¶¶[0092], [0096]-[0097]).
Prostaglandins are understood as described in the prior art (see, e.g., US 5,151,444 at col I at line 1 to col II at line 50). Prostaglandin B 1 (PGB1) is understood to be (13E,15S)-15-Hydroxy-9-oxoprosta-8(12),13-dien-1-oic acid, and correspond to CAS Number 13345-51-2, and the compound is understood to have the following structure:
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“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Additional claim interpretations are set forth below.
Withdrawn Claim Rejections
The rejection of claims 1 and 6 under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US2013/0225643A1 (Sakai et al; Aug. 29, 2013) is withdrawn in view of the amendments to claim 1 filed 2/06/2026, which exclude from the pending claim scope methods of treating Parkinson’s disease by administering PGE1, PGE2, or a combination of both PGE1 and PGE2.
The rejection of claims 1 and 6-7 under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US2013/0309330A1 (Mastronardi; Nov. 21, 2013) is withdrawn in view of the amendments to claim 1 filed 2/06/2026, which exclude from the pending claim scope methods of treating Parkinson’s disease by administering PGF2α.
The rejection of claims 1, 4, and 6-7 under 35 U.S.C. 102(a)(2) as being clearly anticipated by US20200038352A1 (Yoon et al; Feb. 6, 2020; Filing date Sep. 20, 2016) is withdrawn in view of the amendments to claim 1 filed 2/06/2026, which exclude from the pending claim scope methods of treating Parkinson’s disease by administering PGA1, PGA2, and PGJ2.
Claim Rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over US2013/0309330A1 (Mastronardi; Nov. 21, 2013; cited in previous action) as applied to claims 1 and 6-7 above, and further in view of US 5,151,444 (Ueno et al; Sep. 29, 1992; cited in previous action).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1 and 6-7 and the general treatment of Parkinson’s disease by administering prostaglandins, US’330 teaches and claims methods of treating neuropsychiatric conditions by administering a therapeutically effective amount of a composition comprising a prostaglandin or prostaglandin derivative (see, e.g., US’330 at claim 50), to a human patient (see, e.g., US’330 at claim 69), wherein administration may include oral administration routes (see, e.g., US’330 at claim 69), and wherein “neuropsychiatric condition” explicitly encompasses Parkinson’s disease (see, e.g., US’330 at ¶¶[0015], [0021], [0065]). Accordingly, the general methods of treating Parkinson’s disease by orally administering a subject a prostaglandin or prostaglandin derivative was already known and disclosed in the prior art, circa 2013. Regarding the concentration administered, US’330 identifies that the concentration of prostaglandin can vary (see, e.g., US’330 at ¶¶[0009]-[0010]), but exemplifies the usage of prostaglandins in animal models at 40 mg/kg (see, e.g., US’330 at ¶¶[0110] and table 1 at [0101]).
The primary reference differs from the originally elected subgenus as follows: US’330 does not explicitly recite the oral administration of the specific prostaglandin of PGB1 to humans for the treatment of Parkinson’s disease. Therefore, the relevant issue is whether or not it would have been obvious to practice the prior art methodology utilizing the prostaglandin of PGB1.
US’330 identifies that the term “prostaglandin” encompasses all prostaglandins, including those classified as Prostaglandin B, and those disclosed by US5151444 (see, e.g., US’330 at ¶[0030]). US’444 describes and defines prostaglandins, including PGBs (see, e.g., US’444 at col I at line 1 to col II at line 50), and including PG1s based upon the placement of a double bond in the ω-chain (see id). Accordingly, an artisan would readily appreciate that PGB1 was known and reasonably indicated and suggested for use in the methods of US’330.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
First, the invention is the combination of prior art elements (i.e., prostaglandins, including PGB1) according to known methods of treating Parkinson’s disease by orally administering a prostaglandin to human patients as taught by the primary reference, to yield predictable results, namely the treatment of Parkinson’s disease exactly as taught and suggested by the primary reference (see, e.g., MPEP §§ 2143(I)(A), (F), (G)). Furthermore, each prior art element merely performs its art recognized function in combination as it does separately.
Second, the invention is the simple substitution of one known prostaglandin (i.e., PGB1) in place of another prostaglandin (i.e., PGF2α, PGE1, or PGE2), in the prior art method of the primary reference for treating Parkinson’s disease by orally administering a prostaglandin to human patients as taught by the primary reference, wherein such substitution would be expected and predicted to yield predictable results, namely the treatment of Parkinson’s disease exactly as taught and suggested by the primary reference (see, e.g., MPEP §§ 2143(I)(B), (G)).
Third, the claimed invention is the obvious combination of equivalent prostaglandins, according to known methods of treating Parkinson’s disease by orally administering a prostaglandin to human patients as taught by the primary reference, wherein the difference is that an additional prostaglandin (i.e., PGB1) is orally administered to such patients in addition to other prostaglandins (e.g., PGF2α, PGE1, PGE2, and/or other prostaglandins explicitly enumerated in the claims of the primary reference); however, per MPEP § 2144.06(I), "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980); accordingly, simply modifying the prior art methodology by co-administering an additional prior art prostaglandin (i.e., PGB1) is obvious because the primary reference teaches that individual prostaglandins are capable of treating Parkinson’s disease, and therefore the combination of prostaglandins (including PGB1) would also predictably and expectedly treat Parkinson’s disease (see MPEP § 2144.06(I)).
Accordingly, the claimed invention is obvious in view of the prior art.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the prior art to administer known compounds to a known patient population via a known route of administration at a known concentration to obtain the results explicitly taught and disclosed by the prior art.
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, or 716.02 have been placed on record to date.
Accordingly, claims 1 and 6-7 are rejected as obvious.
Response to Arguments
Applicant's arguments filed 2/06/2026 have been fully considered but they are not persuasive. Arguments pertaining to withdrawn rejections are moot. Applicant traverses the maintained rejection under 35 USC 103 at pages 6-11 (see, e.g., Reply filed 2/06/2026 at 6 at 2nd full ¶ to 11 at 1st full ¶).
Applicant reiterates the rejection and recites caselaw and MPEP citations, but does not apply such caselaw or MPEP citations to the merits of the instant rejection (see, e.g., Reply filed 2/06/2026 at 6 at 2nd full ¶ to 7 at 1st partial ¶). Accordingly, the holdings of such cases are neither disputed nor dispositive of the instant rejection.
Allegations that the cited passages relied upon by Examiner in the rejection do not support or address all claimed limitations: It is the Examiner’s understanding that Applicant is alleging that US’330 does not pertain to the treatment of Parkinson’s disease (see, e.g., Reply filed 2/06/2026 at 7 at 1st full ¶, 7-8 at bridging ¶). This is factually incorrect, and therefore not persuasive because US’330 literally and explicitly teaches and claims methods of treating neuropsychiatric conditions by administering a therapeutically effective amount of a composition comprising a prostaglandin or prostaglandin derivative (see, e.g., US’330 at claim 50), to a human patient (see, e.g., US’330 at claim 69), wherein administration may include oral administration routes (see, e.g., US’330 at claim 69), and wherein “neuropsychiatric condition” explicitly encompasses Parkinson’s disease (see, e.g., US’330 at ¶¶[0015], [0021], [0065]). Arguments based upon factually incorrect information are not persuasive.
Allegations that obviousness is not established when diseases are only mentioned five times: It is the Examiner’s understanding that Applicant is suggesting that US’330 does not render treatment of Parkinson’s disease obvious because “In the entire disclosure of US’330, Parkinson’s disease is only mentioned five times” (see, e.g., Reply filed 2/06/2026 at 7 at 1st full ¶, 7-8 at bridging ¶). The underlying legal rationale for Applicant’s argument is unknown because a determination of obviousness is not rebutted if a disease is mentioned five or fewer times in a disclosure. Rather, prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses, including nonpreferred and alternative embodiments (see, e.g., MPEP §§ 2123(I)-(II)). Accordingly, such arguments are not persuasive because US’330 literally teaches the treatment of neuropsychiatric conditions, including Parkinson’s disease, by administering a therapeutically effective amount of a composition comprising a prostaglandin or prostaglandin derivative (see, e.g., US’330 at claim 50, 69, ¶¶[0015], [0021], [0065]).
Allegations that the prior art provides additional information that was not relied upon by the Examiner: It is the Examiner’s understanding that Applicant is suggesting that US’330 does not render treatment of Parkinson’s disease obvious because US’330 discloses methods of treating other neuropsychiatric conditions besides just Parkinson’s disease (see, e.g., Reply filed 2/06/2026 at 7 at 1st full ¶, 7-8 at bridging ¶, 8 at final ¶). It is neither disputed nor dispositive of obviousness that the prior art references informs artisans of additional information and may render additional, unexamined inventions obvious. The relevance of the existence of such additional teachings to the instant rejection is not unambiguously explained by the Applicant. However, the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), and here the additional information does not detract or erase the disclosures relied upon by the Examiner in the rejection of record.
Allegations suggesting the references “teach away”: It is the Examiner’s understanding that Applicant is suggesting that the disclosure of methods of treating other neuropsychiatric conditions besides just Parkinson’s disease constitutes a “teaching away” from the claimed invention (see, e.g., Reply filed 2/06/2026 at 7 at 1st full ¶, 7-8 at bridging ¶, 8 at final ¶). Examiner notes that this argument is not persuasive because the disclosure of additional methods does not “teach away” from the claimed invention since they do not actually “criticize, discredit, or otherwise discourage the solution claimed” (see, e.g., MPEP § 2141.02(VI)). Applicant has not identified any disclosure that “criticizes, discredits, or otherwise discourages the solution claimed”. Accordingly, no “teaching away” has been identified on record.
Allegations suggesting “inoperability” or lack of enabling disclosure regarding a prior art reference: It is the Examiner’s understanding that Applicant’s statements amount to a suggestion that the prior art is not fully enabled or operable (see, e.g., Reply filed 2/06/2026 at 7 at 1st full ¶, 7-8 at bridging ¶, alleging that the recitation of Parkinson’s disease by the prior art “would not constitute an “enabling” disclosure). If Applicant is attempting to allege that the prior art is not enabling or inoperable Applicant is directed to MPEP § 2121(I), which notes that the prior art is presumed fully enabled for all that it discloses, and the burden is on the Applicant to rebut the presumption of operability (see, e.g., MPEP § 2121(I); MPEP § 716.07). No evidence of inoperability commensurate in scope with the requirements of MPEP § 716.07 have been placed on record at this time; critically, arguments of counsel cannot take the place of evidence in the record (see, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965), and evidence is required to rebut the presumption of operability. The Examiner’s position is that the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)). Accordingly, the Applicant has not satisfied their burden to rebut the presumption of operability of the prior art at this time (see, e.g., MPEP § 2121(I); MPEP § 716.07).
Allegations addressing less than all references relied upon by the Examiner: It is the Examiner’s understanding that Applicant alleges that US’330, considered alone, does not teach PGB1 (see, e.g., Reply filed 2/06/2026 at 7-8 at bridging ¶, 10 at 2nd full ¶), and that US’444, considered alone, does not teach the treatment of Parkinson’s disease (see, e.g., Reply filed 2/06/2026 at 9 at 1st ¶). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Allegations suggesting “lack of predictability” or “lack of reasonable expectation of success”: It is the Examiner’s understanding that Applicant is alleging a lack of predictability or otherwise a lack of reasonable expectation of success (see, e.g., Reply filed 2/06/2026 at 8 at 1st full ¶, 9 at 2nd ¶, 10 at 2nd full ¶). This is not persuasive because the Applicant’s assertions do not reflect the proper legal standards for evaluating predictability. MPEP § 2143.02(II) explains that “[o]bviousness does not require absolute predictability”, but instead clarifies that only “at least some degree of predictability is required” (see, e.g., MPEP § 2143.02(II)). Here, the rejection explicitly addresses predictability and reasonable expectation of success, but Applicant fails to address the explicitly identified predicted and expected results set forth in the rejection. Here, the Examiner’s basis for “predictability” is merely based upon the presumption that the prior art is fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). As explained at MPEP § 2143.02, predictability and reasonable expectation of success are satisfied when “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art”. Here zero evidence of unexpected results commensurate in scope with the requirements of MPEP 716.02 have been set forth on record, all elements of the claimed invention were known in the prior art, one of ordinary skill was fully enabled to combined each component using routine methods in the biochemical arts per the guidance of the primary reference, and the elements would have merely performed their art-recognized, respective functions (see Rejection, above). Accordingly, such arguments are not persuasive.
Allegation regarding lack of motivation to arrive at the claimed invention: It is the Examiner’s understanding that Applicant is alleging that there is no motivation or rationale for arriving at the instantly claimed invention (see, e.g., Reply filed 2/06/2026 at 8 at 1st full ¶, 8 at 2nd full ¶, 9 at 2nd ¶, 9-10 at bridging ¶, 10 at 1st full ¶). In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the rejection explicitly and literally identifies three exemplary rationales supporting a determination of obviousness, which are explicitly labeled in the rejection, and supported by MPEP §§ 2143(I)(A), (B), (F), (G) and MPEP § 2144.06(I) (see rejection, above). However, Applicant fails to acknowledge or dispute such rationales. All holdings that are not specifically disputed on record, are understood to be undisputed.
Applicant appears to suggest the instant disclosure is not enabling in the absence of exemplification: It is the Examiner’s understanding that Applicant is alleging that in the Parkinson’s disease arts, that a disclosure is non-enabling in view of a description of a problem to be solved (see, e.g., Reply filed 2/06/2026 at 7-8 at bridging ¶), but in the absence of any “exemplified” methods (see, e.g., Reply filed 2/06/2026 at 8 at 1st full ¶, 9 at 2nd ¶). Examiner notes that if such statements and standards for the art are correct, then the instant disclosure would be deemed non-enabling, since zero exemplified methods of treating Parkinson’s disease in a patient were reduced to practice. Currently, Examiner finds the instant disclosure enabling in view of the prior art of US’330, which is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), absent evidence to the contrary. Upon evidence or admission that exemplified reductions to practice are required in this specific art, the instant claims may be rejected under 35 USC 112(a), for lacking enablement.
Applicant addresses a rationale for supporting obviousness that was not relied upon by the Examiner: It is the Examiner’s understanding that Applicant is alleging that the instant rejection does not support a determination of obviousness under the rationale of MPEP § 2143(I)(E) (i.e., finite number of solutions) (see, e.g., Reply filed 2/06/2026 at 8 at 2nd full ¶ tp 3rd full ¶, 9-10 at bridging ¶). This is neither disputed nor dispositive because the rejection is not premised upon this rationale. Rather, the explicitly recited rationales supporting a determination of obviousness are set forth in the rejection and are MPEP §§ 2143(I)(A), (B), (F), (G) and MPEP § 2144.06(I). Accordingly, arguments directed towards a rationale not relied upon by the Examiner are insufficient to rebut the merits of the rejection based upon different, distinct rationales.
Allegations that a disclosed disease is not obvious because other diseases are also disclosed: It is the Examiner’s understanding that Applicant is suggesting that the disclosure of methods of treating other neuropsychiatric conditions besides just Parkinson’s disease renders the invention less obvious because “it would not have been obvious to select Parkinson’s disease from the long list of neuropsychiatric conditions and cognitive disorders taught by US’330” (see, e.g., Reply filed 2/06/2026 at 7 at 1st full ¶, 7-8 at bridging ¶, 8 at final ¶, 9-10 at bridging ¶, 10 at 1st full ¶). This is not persuasive because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)). Furthermore, the courts have previously noted that
"[r]eading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle."
(see, e.g., Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945), at 335)
and the court did not recite an exception if the “list” was “long” (see id.). This is reasonable because if each of the alternatives merely perform an art-recognized function in the absence of any unexpected results, then the outcome remains predictable and expected, regardless of the total number of alternatives. Furthermore, the Court has stated that
"[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 Int'l Co. v. Teleflex Inc., 550 U.S. 398 , 417 , 127 S. Ct. 1727 , 167 L. Ed. 2d 705 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273 , 282, 96 S. Ct. 1532 , 47 L. Ed. 2d 784 (1976)).
Likewise, the Supreme Court has rejected rigid tests for obviousness and has emphasized that
[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 416.
And has also emphasized that
“If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 417.
Here, all aspects of the claimed method were already known in the art, all compounds recited were prior art elements, used in prior art methods exactly as taught by the prior art, wherein the expected and predicted results are the explicitly taught and disclosed results identified in the prior art. Finally, given modern search engine techniques, it is well-within the ordinary skill in the Parkinson’s disease treatment arts to simply perform a text search for documents pertaining to the treatment of Parkinson’s disease, which would yield US’330. Accordingly, such arguments are not persuasive.
Recited caselaw is not explained and does not appear applicable to the instant facts: It is the Examiner’s understanding that Applicant alleges that the cited references do not direct the skilled person to select a particular combination of elements, and refers to In re Arkley, In re Baird, and In re Jones in support of this position (see, e.g., Reply filed 2/06/2026 at 9-10 at bridging ¶). This argument is not persuasive as explained in the preceding paragraph, and Applicant’s reliance upon such caselaw is misplaced. First, regarding the cited caselaw, Examiner does not dispute the holdings of such cases, but notes that in the absence of any analysis or explanation of why such cases are applicable to the present facts of the instant case, such quotes are not dispositive of obviousness. Second, to the contrary, the caselaw does not appear to support Applicant’s position; for Example, In re Arkley identifies that
“[P]icking and choosing may be entirely proper in the making of a 103, obviousness rejection….but it has no place in the making of a 102, anticipation rejection.”
In re Arkley, 455 Fall that.2d 586, 587–588 (CCPA 1972).
The maintained rejection is under 103, and therefore, in direct contrast to the Applicant’s position, In re Arkley clearly identifies that “picking and choosing may be entirely proper in the making of a 103”. Furthermore, the reliance upon In re Baird is misplaced, because the holding pertained to a chemical genus, and the court explained that “[a] disclosure of millions of compounds does not render obvious a claim to three compounds, particularly when that disclosure indicates a preference leading away from the claimed compounds.” Here, “millions” of chemical compounds are not at issue, and therefore the relevance of In re Baird to the instant facts are unknown and not explained. Accordingly, such arguments are not persuasive because the facts of the cases do not appear relevant to the rejection at issue and the facts of record.
Recited caselaw is not explained and does not appear applicable to the instant facts: It is the Examiner’s understanding that Applicant recites and refers to multiple cases (see, e.g., Reply filed 2/06/2026 at 10 at 1st full ¶). The holdings of these cases are neither disputed nor dispositive of obviousness in the instant case, because the Applicant has failed to identify why the facts of each case are germane to the instant rejection and facts at issue.
Arguments regarding unclaimed limitations: It is the Examiner’s understanding that Applicant alleges that they have provided evidence pertaining to an unclaimed “MPTP-induced animal model of PD” (see, e.g., Reply filed 2/06/2026 at 10-11 at bridging ¶). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., MPTP-induced animal models) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
No evidence of unexpected results or criticality of range has been placed on record: Examiner notes that Applicant refers to experimental data (see, e.g., Reply filed 2/06/2026 at 10-11 at bridging ¶). However, zero evidence of unexpected results sufficient to rebut prima facie obviousness and commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 has been placed on record. No evidence showing criticality of range has been placed on record. Rather the instant claims appear to only achieve the predicted and expected results taught and suggested by the prior art, and therefore evidence confirming the expectations of the prior art actually weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)). In addition, any suggestion of additional results would not necessarily result in non-obviousness, because the fact that the inventor may recognize another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Allegations suggesting “skepticism of experts”: It is the Examiner’s understanding that Applicant’s statements amount to a suggestion that the Examiner’s position would be met with skepticism of experts (see, e.g., Reply filed 2/06/2026 at 7 at 1st full ¶, 7-8 at bridging ¶, 8 at final ¶, 9-10 at bridging ¶, 10 at 1st full ¶). If Applicant means to suggest the existence of skepticism of experts, such evidence should be filed per MPEP § 716.05 as evidence is required to establish skepticism of experts. In the absence of such evidence, such statements are understood to be unsupported conjecture of counsel. The prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), and no objective evidence rebutting this presumption has been placed on record to date.
Accordingly, all arguments have been fully considered but not found persuasive for reasons of record. Accordingly, the rejection is maintained.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US2013/0225643A1 (Sakai et al; Aug. 29, 2013; cited in previous action) claims a method of treating Parkinson’s disease (see, e.g., US’643 at claim 41) using a method that includes administering a therapeutically effective amount of any prostaglandin derivative (see, e.g., US’643 at claim 50), wherein “prostaglandin derivative” is defined to explicitly include PGE1 and/or PGE2 (see, e.g., US’643 at ¶[0157]). Accordingly, an artisan would at once envisage methods of US’643 for treating Parkinson’s disease by administering PGE1, PGE2, or a combination of both PGE1 and PGE2.
US20200038352A1 (Yoon et al; Feb. 6, 2020; Filing date Sep. 20, 2016; cited in previous action) discloses a method of treating subjects for Parkinson’s disease (see, e.g., Yoon at claims 11-13, ¶[0099]) by administering “an effective amount” of PGA1 or PGA2 (see, e.g., Yoon at claim 14, ¶[0103]), wherein “administration” would be readily envisaged and understood to include oral administration (see, e.g., Yoon at claims 11-14, ¶[0107]). In addition, Yoon discloses a method of treating subjects for Parkinson’s disease (see, e.g., Yoon at claims 11-13, ¶[0099]) by administering “an effective amount” of a “cyclopentenone prostaglandin” (see, e.g., Yoon at claim 11]), wherein “administration” would be readily envisaged and understood to include oral administration (see, e.g., Yoon at claims 11-14, ¶[0107]). The term “cyclopentenone prostaglandin” is explicitly defined as a narrow subgenus of compounds, including PGJ2 (see, e.g., Yoon at ¶[0046]), and therefore an artisan would readily envisage and understand that the method could be practiced utilizing PGJ2.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654