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
Applicant’s election without traverse of antiviral and peptoids recited in claim 90 in the reply filed on 10/13/25 is acknowledged. Please note that the claims 1-20 were canceled and claim 90-97 were added in response to the Restriction requirement.
Claims 90-97 are under consideration.
Claim Objections
Claim 90 is objected to because of the following informalities: There is a typographical error in the last peptoid of claim 90. “NLvs” should be amended to “NLys”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 90-97 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabled for TM1-TM9 as anti-viral peptoids against HSV but does not reasonable provide enablement for TM10 as an antiviral peptoid. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
As stated in MPEP 2164.01(a), “there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
The factors to be considered when determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, were described in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as:
1. the nature of the invention;
2. the breadth of the claims;
3. the state of the prior art;
4. the relative skill of those in the art;
5. the predictability or unpredictability of the art;
6. the amount of direction or guidance presented [by the inventor];
7. the presence or absence of working examples; and
8. the quantity of experimentation necessary [to make and/or use the invention.
(1) The Nature of the Invention and (2) The Breadth of the claims
Claim 90 is drawn to a persona lubricant comprising a lubricious medium and disposed in said medium a pharmaceutically effective amount of an antiviral agent against HSV-1 wherein said antiviral agent comprises a peptoid and said peptoid is a poly-N-substituted glycine compound.
The claims will be given its broadest reasonable interpretation. The applicable rule for interpreting the claims is that “each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description.” See MPEP 2163(II)(1), citing In re Morris, 127 F.3d 1048, 1053-1054; 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). In view of this rule, Claim 1 is drawn a persona lubricant comprising a lubricious medium and peptoids that are antiviral against HSV-1.
(3) The state of the prior art and (5) The predictability or unpredictability of the art
The prior art is not enabling for the peptoids as antimicrobial peptoids. Barron et al. teach the peptides have broad spectrum activity (please see the 103 rejection below). However, there was no art found that teaches or suggests the claimed peptoids have antiviral activity.
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Given this fact, historically the development of new drugs has been difficult and time-consuming. Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art.
(4) The relative skill of those in the art
MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples
The applicant provided sufficient guidance or direction regarding the potential antiviral activity against HSV-1 with TM1-9 (Fig. 1). It should be noted that Fig. 3 does not indicate significance and the results appear to be variable. However, TM10 did not have activity against HSV-1 and appears worse than the control. Therefore the specification is enabled for TM1-9 peptoids as antiviral peptoids against HSV-1.
(8) The quantity of experimentation necessary (to make and/or use the invention)
Owing to the factors listed above, especially in points 6 and 7, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor. MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
The instant breadth of the claim is broader than the disclosure, specifically, the instant claims are directed to peptoids that are antiviral to HSV-1, however the specification and prior art do not provide support for this.
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 90-97 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.
Claim 90 is indefinite because it is unclear if the claim requires a single peptide from the list of peptides or multiple peptides from the list or specific combinations of peptoids due to the alternating “or” and “and” connectors. A person of ordinary skill in the art would not be able to determine the metes and bounds of the claim. For purposes of examination, the claim is interpreted to require a single peptoid.
Regarding claim 96, the phrase “including” in this context is interpreted as “for example” or “such as”. The phrase "including" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 91-97 are rejected for depending on claim 90.
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.
Claims 90-97 are rejected under 35 U.S.C. 103 as being unpatentable over Moench (USPN 8,236,370) in view of Barron et al. (US2010/0036088) as evidenced by Al- Singh et al. (Complexation an overview, Science direct; 2018) as evidenced by Al-Kinani et al. (Advanced Drug Delivery Reviews Volume 126, 15 February 2018, Pages 113-126) and Singh et al. (Science direct 2024).
Moench teaches a condoms with a sufficient quantity of microbicidal composition to provide for inactivation of pathogens (Abstract). With respect to claim 90, Moench teaches and claims a condom having an inner and out surface, comprising a cross-linked polyacrylic acid (claim 1). Moench teach the condoms include a lubricant, meeting the limitation of “lubricious medium”. (claim 22, col. 1; col. 4, lines 46-50; col. 5, lines 54-56; Ex. 1). With respect to the limitation “personal lubricant”, Moench teaches the composition includes a lubricant (col. 4, lines 46-50). Please note that the instant specification does not define “personal lubricant”, therefore the broadest reasonable interpretation includes a lubricant on the condom of Moench.
Moench does not teach the condom with a microbicidal comprises the claimed poly-N-substituted glycine compound. However, the teachings of Barron et al. cure this deficiency.
Barron et al. teach antimicrobial peptoid compounds used against bacteria effectively. Barron et al. teach the peptoid [0016]: H—Ntridec—NLys—Nspe—Nspe—NLys—NH2, which is identical to the 3rd peptoid of claim 90. Table 1 discloses H-(Nlys-Nspe-NSpe)4-NH2, which is identical to the first peptide of claim 90. Barron et al. teach the peptoids exhibited broad spectrum antimicrobial activity [0079].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to incorporate the antimicrobial peptoid of Barron et al. into the lubricant/condom of Moench for the inactivation of pathogens. A person of ordinary skill in the art would have a motivation because Barron et al. teach peptoid compounds that exhibit broad spectrum antimicrobial activity and have a motivation to incorporate the peptoids in a condom or lubricant to prevent transmission of a microbe. There is a reasonable expectation of success given that Moench teaches incorporation of microbicials in the condom/lubricant and Barron et al. teach the broad spectrum effectiveness of the peptoids.
With respect to the limitation “an antiviral agent against HSV-1”, the peptoids from Barron et al. would inherently have all of the activities and properties of the composition of claim 90. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, Barron et al. teach the same poly-N-substituted glycine compounds as instantly claimed. Therefore, the same peptoids would necessarily have the same functions. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Importantly, MPEP 2112 states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer” and “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.
With respect to claim 91, Moench teaches materials used in the compositions include carbomers, such as Cabopols (col. 13, lines 13-14). The instant specification does not define anionic microgel. The broadest reasonable interpretation of anionic microgel, includes carbomers. As evidenced by Al-Kinani et al., carbomer or Carbopol is an anionic high MW synthetic polymer comprised of poly acrylic acid cross linked with either allyl ethers of sucrose of allyl ethers of pentaerythrityl (para. 2.2.2). Please note that MPEP 2131.01 states: that an extra reference or evidence can be used to show an inherent characteristic of the thing taught by the primary reference. In the instant case, the is relied upon only to establish that carbomers are anionic microgels.
With respect to claim 92, the instant specification does not define “complexation”. As evidenced by Singh et al., complexation is the process of formation of a stable complex, which may be covalent, but is commonly formed through non covalent interactions between two compounds (bottom of p. 2 and continued to top of p. 3). Please note that MPEP 2131.01 states: that an extra reference or evidence can be used to show an inherent characteristic of the thing taught by the primary reference. In the instant case, Barron et al. teach the peptoids are cationic (positively charged) and it would have been obvious to a person of ordinary skill in the art that the peptoid and anionic microgel would readily complex because the polyanionic polyacrylic acid (carbomer) is negatively charged and the component would complex through electrostatic interactions. There is a reasonable expectation of success given that the definition of complexation includes formation of a covalent or noncovalent complex.
With respect to claim 93, Moench teaches and claims a condom having an inner and out surface, comprising a cross-linked polyacrylic acid (claim 1). A condom is a contraceptive device. As indicated above, Moench teaches a lubricant, meeting the limitations of claim 93.
With respect to claims 94-96, Moench teaches the condom (penile barrier device) comprising a first composition that is disposed along at least a portion of the inner surface of the condom (col. 4, lines 22-30). Moench teaches the composition includes a cross-linked polyacrylic acid includes a carbomer (col. 4, 44-45). With respect to the limitation “is released from said polyacrylic acid coated surface”, please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case Moench et al. and Barron et al. make obvious the claimed contraceptive device which is therefore capable of performing the intended use. Furthermore, the MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, Moench and Barron et al. make obvious the same contraceptive device, therefore the same contraceptive device would have the same properties.
With respect to claim 97, Moench teach the condoms such as Trojan ENZ made with latex which is elastomeric material.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 90-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 123 of copending Application No. 17/640,322 (reference application) in view of Moench (USPN 8,236,370). Although the claims at issue are not identical, they are not patentably distinct from each other. The copending Application claims a method for treating a subject for HSV-1 infection comprising the same peptoids as instantly claimed. The copending Application does not claim a lubricant or contraceptive comprising the peptoids, however the teachings of Moench cure this deficiency.
The teachings of Moench are presented above in detail.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to incorporate the peptoid of the copending application into the lubricant/condom of Moench for the inactivation of pathogens. A person of ordinary skill in the art would have a motivation because the copending Application teaches treatment of HSV, which is sexually tranmittedand have a motivation to incorporate the peptoids in a condom or lubricant to prevent transmission of a virus. There is a reasonable expectation of success given that Moench teaches incorporation of microbicials in the condom/lubricant.
With respect to claim 91, Moench teaches materials used in the compositions include carbomers, such as Cabopols (col. 13, lines 13-14). The instant specification does not define anionic microgel. The broadest reasonable interpretation of anionic microgel, includes carbomers. As evidenced by Al-Kinani et al., carbomer or Carbopol is an anionic high MW synthetic polymer comprised of poly acrylic acid cross linked with either allyl ethers of sucrose of allyl ethers of pentaerythrityl (para. 2.2.2). Please note that MPEP 2131.01 states: that an extra reference or evidence can be used to show an inherent characteristic of the thing taught by the primary reference. In the instant case, the is relied upon only to establish that carbomers are anionic microgels.
With respect to claim 92, the instant specification does not define “complexation”. As evidenced by Singh et al., complexation is the process of formation of a stable complex, which may be covalent, but is commonly formed through non covalent interactions between two compounds (bottom of p. 2 and continued to top of p. 3). Please note that MPEP 2131.01 states: that an extra reference or evidence can be used to show an inherent characteristic of the thing taught by the primary reference. In the he peptoids are cationic (positively charged) and it would have been obvious to a person of ordinary skill in the art that the peptoid and anionic microgel would readily complex because the polyanionic polyacrylic acid (carbomer) is negatively charged and the component would complex through electrostatic interactions. There is a reasonable expectation of success given that the definition of complexation includes formation of a covalent or noncovalent complex.
With respect to claim 93, Moench teaches and claims a condom having an inner and out surface, comprising a cross-linked polyacrylic acid (claim 1). A condom is a contraceptive device. As indicated above, Moench teaches a lubricant, meeting the limitations of claim 93.
With respect to claims 94-96, Moench teaches the condom (penile barrier device) comprising a first composition that is disposed along at least a portion of the inner surface of the condom (col. 4, lines 22-30). Moench teaches the composition includes a cross-linked polyacrylic acid includes a carbomer (col. 4, 44-45). With respect to the limitation “is released from said polyacrylic acid coated surface”, please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case Moench et al. and Barron et al. make obvious the claimed contraceptive device which is therefore capable of performing the intended use. Furthermore, the MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, Moench and Barron et al. make obvious the same contraceptive device, therefore the same contraceptive device would have the same properties.
With respect to claim 97, Moench teach the condoms such as Trojan ENZ made with latex which is elastomeric material.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/TARA L MARTINEZ/Examiner, Art Unit 1654