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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Acknowledgment is made of applicants' claim for foreign priority to Chinese applications PCT/CN2021/139750 filed on Dec 20, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 10, 2024, Jul 11, 2025, and Dec 02, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Claims
Claims 1, 3-4, 6-16, 18, 20, 22, 23, 26, and 28 are pending and under examination. Claims 2, 5, 17, 19, 21, 24-25, and 27 are cancelled.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings are of poor quality. It is also noted that the drawings have several informalities such as Figure 10 is a graph with no axis labels. Figure 12 is entirely unclear. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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, 3-4, 6-16, 18, 20, 22, 23, 26, and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 encompasses all opsins across all animals, that are coupled to Gq signaling and are sensitive to light, any fragments, or variants, all homologs, paralogs, orthologs. It is noted that the specification only specifically taught opsin 5 in chicken, turtle, mice and human (See Example 1). It is noted that table 9 lists chicken opsin 5 orthologs from some vertebrates. It is inconceivable that the specification provides support for all opsins in all living organisms. Accordingly, the scope of the claim is immense and is not supported by the specification. It is clear that the claims cover species of cOpn5 beyond those exemplified in the specification. Nor does the specification provide or identify common structural features, conserved motifs analysis or general correlation between the variation and the claimed functional outcome sufficient to demonstrate possession of the full scope of the claimed genus. As such it is submitted the claim lacks written description. Claims 3-4, 6-16, 18, 20, 22, 23, 26, and 28 inherit the rejection based on their dependency.
It is further noted regarding claims 3-4, 6-11 that, although the specification discloses several full-length wildtype opsins, these disclosures are limited to naturally occurring species and do not disclose or characterize the broad genus of sequence variants falling within the claimed ≥70% identity threshold. As such the specification does not provide representative sequences spanning the full-range of the claimed identity spectrum that possess the claimed activity. Further structural or sequence-based rules for identifying which substitutions preserve Gq signaling and retinal light restorative activity are absent. Neither does the specification establish a correlation between percent identity and functional retention of claimed biological activity. It is also pointed out that there is no support for all orthologs present in all species of opsins in all the claimed animals recited in claim 7.
Claims 8 and 9 encompass opsin 5 from all the known chicken and turtle species respectively. However, it is submitted that the specification only exemplified opsin 5 of SEQ ID NO: 1 or 2. As such the specification does not provide representative sequences spanning the full-range of the claimed opsin 5 from the claimed animals.
Claims 22-23, 26, and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 22-23, 26, 28 require a method of preventing a disease or treating a condition involving loss of sensitivity to light in retina. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented (3) the presence or absence of working examples, (4) the nature of the invention, a (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The claims are drawn to a method of preventing a disease or treating a condition involving loss of sensitivity to light in retina. While the person of ordinary skill in the art would have a reasonable expectation of success of using chicken opsin 5 for restoration of photoreceptor degeneration, retinal degeneration, or exposure to MNU, the specification did not support use of all opsins, opsin variants, homologs, orthologs, paralogs or fragments for all retinal disease contexts. It is noted that C3H/HeNCrl mice are a model for retinal degeneration and are not models for blindness or visual impairment resulting from retinal ganglion cells, or loss of output neurons, where the biological readout is still deficit in light perception. The breadth of the claim encompasses glaucoma, optic neuritis, cortical blindness among others. It is for example pointed out that “glaucomas are a group of progressive optic neuropathies characterized by degeneration of retinal ganglion cells and resulting changes in the optic nerve head. Loss of ganglion cells is related to the level of intraocular pressure, but other factors may also play a role.” (See Weinreb Abstract; See PTO-892). Further, Bennet indicated that “Optic neuritis is a common clinical manifestation of central nervous system inflammation.” (See Bennet Abstract; See PTO-892). It is further pointed out that the specification does not provide methods of “preventing” retinal degeneration using the claimed composition. It is generally known that retinal degeneration is caused by chemical exposure or biological factors that are not “preventable.” For example, Jones taught that “Retinal degeneration and remodeling encompasses a group of pathologies at the molecular, cellular and tissue levels that are initiated by inherited retinal diseases like retinitis pigmentosa (RP), genetic and environmental diseases like age-related macular degeneration (AMD) and other insults to the eye/retina including trauma and retinal detachment.” (See Jones, first para, See PTO-892).
Additionally, the applicants have provided no direction for the claimed method to prevent retinal degeneration, or treat diseases or conditions that are not caused by retinal degeneration. The specification demonstrates the ability of the cOPN5 to restore retinal degeneration, especially where the degeneration is characterized by external retinal failure. (See Example 4). It is also pointed out that there is no explicit model targeting each and every cell type of retina such as a photoreceptor cell, a retinal rod cell, a retinal cone cell, a retinal ganglion cell, a bipolar cell, a ganglion cell, a horizontal cell, a multipolar neuron, a Muller cell or an Amacrine cell. While lack of a working embodiment cannot be a sole factor in determining enablement, the absence of substantial evidence, in light of the unpredictable nature of the art and the direction applicants present, provides additional weight to the lack of enablement in consideration of the Wands factors as a whole. Thus, one of ordinary skill in the art would not have a reasonable expectation of successfully treating any other disease than retinal cell degeneration by performing the claimed method.
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 4, 7-11, 12, 15, 16 and 22-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 4, 7, 12, 15, 16 and 22-23 recite preferable embodiments. Such exemplary language renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 also recites “such as” rendering the claim indefinite.
Claim 7 recites certain limitations in parenthesis. It is unclear if these limitations are part of the claimed invention.
Claims 8-11 require a chicken or turtle opsin 5. It is however unclear which species of chicken or turtle are encompassed by the claim. It is understood by a person of ordinary skill in the art that there are more than one species of turtle and chicken exist. As such the metes and bounds of this claim are unclear.
Claim Interpretation
Claim limitations directed to the intended use or purpose of a composition (e.g., “for restoring sensitivity to light of the retinal cell through activating Gq signaling”) do not impart patentable weight to the claimed composition when the prior art discloses the identical or structurally indistinguishable composition.
Where a prior art reference discloses a composition that meets all structural limitations of the claimed subject matter, additional recitation of an intended use or functional result does not render the claim novel or non-obvious. Such language merely describes a property or intended application of the prior art composition and does not distinguish the claimed subject matter unless the functional limitation imparts a structural difference to the composition itself.
Claim Rejections - 35 USC § 101
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 1, 3-4, 6-14 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Regarding claims 1, 3-4, and 6-13: The claims are directed to an isolated light-sensitive opsin.
The claim is directed to a composition of matter, which is a statutory category of invention. (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claims encompass naturally occurring opsins, which are naturally occurring. Because the claim is a nature-based product, i.e., a protein, the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. As described in the specification, the isolated proteins such as opsins are identical to what exists in nature (e.g., same protein sequence, and protein structure). The claim thus encompasses proteins that are identical (no difference in characteristics) to naturally occurring protein. Because there is no difference between the claimed and naturally occurring proteins for at least some of the embodiments encompassed by the claim, the claimed opsins do not have markedly different characteristics, and thus are a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338-39 (Fed. Cir. 2014). Thus, the claim recites at least one exception, which may be termed a product of nature. (Step 2A prong 1: YES).
The claim is then analyzed to determine if additional elements integrates the judicial exception into a practical application. The claim recites no additional elements. It is noted that Gq coupling is an inherent property (See Dai et al, IDS 05/10/2024) and restoration of light sensitivity are considered intended use and are not given patentable weight. It is further noted that isolated man-made proteins do not have markedly different characteristics due to their isolation or human manufacture. There is no indication in the specification that isolation of opsins results in the opsins having any characteristics (structural, functional, or otherwise) that are different from the naturally occurring opsins in their natural state. As such the claimed composition does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception. (Step 2A prong 2: NO). Therefore, the claim is directed to a law of nature judicial exception.
The claim is then analyzed to see if it includes any additional features that could add significantly more to the exception. It is noted that recited “for restoring sensitivity to light of the retinal cell” do not account for additional features, as it does not recite active processes or structures that achieve the restoration. As such, there are no additional features that add significantly more to the exception. (Step 2B: NO), the claim does not qualify as eligible subject matter.
Therefore, the claim is directed to a law of nature judicial exception.
The claims are patent ineligible.
Regarding claim 14: The claim is directed to a nucleic acid that encodes the protein of claim 1 (opsin).
The claim is directed to a composition of matter, which is a statutory category of invention. (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claims encompass naturally nucleic acids (DNA/RNA) that encode opsins, which are naturally occurring entities. Because the claim is a nature-based product, i.e., a nucleic acid, the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. The isolated nucleic acids are identical to what exists in nature (e.g., same nucleic acid sequence, and structure). The claim thus encompasses nucleic acids that are identical (no difference in characteristics) to naturally occurring nucleic acid. Because there is no difference between the claimed and naturally occurring nucleic acids for at least some of the embodiments encompassed by the claim, the claimed nucleic acid do not have markedly different characteristics, and thus are a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338-39 (Fed. Cir. 2014). Thus, the claim recites at least one exception, which may be termed a product of nature. (Step 2A prong 1: YES).
The claim is then analyzed to determine if additional elements integrates the judicial exception into a practical application. The claim recites no additional elements. It is further noted that isolated man-made nucleic acids do not have markedly different characteristics due to their isolation or human manufacture. There is no indication in the specification that isolation of nucleic acids results in the any characteristics (structural, functional, or otherwise) that are different from the naturally occurring opsins in their natural state. As such the claimed composition does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception. (Step 2A prong 2: NO). Therefore, the claim is directed to a law of nature judicial exception.
The claim is then analyzed to see if it includes any additional features that could add significantly more to the exception. The claim does not integrate the naturally occurring product into any practical application. (Step 2B: NO), the claim does not qualify as eligible subject matter.
Therefore, the claim is directed to a law of nature judicial exception.
The claims are patent ineligible.
Regarding claim 20: The claim is directed to a cell comprising the naturally occurring nucleic acid of claim 14, which encompasses a retinal cell among many others.
The claim is directed to a composition of matter, which is a statutory category of invention. (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claims encompass naturally cells, such as cells of the retina. Because the claim is a nature-based product, i.e., a cell, the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. The isolated cell is identical to what exists in nature (e.g., same genotype/phenotype). The claim thus encompasses cells that are identical (no difference in characteristics) to naturally occurring cells. Because there is no difference between the claimed and naturally occurring cells for at least some of the embodiments encompassed by the claim, the claimed cells do not have markedly different characteristics, and thus are a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338-39 (Fed. Cir. 2014). Thus, the claim recites at least one exception, which may be termed a product of nature. (Step 2A prong 1: YES).
The claim is then analyzed to determine if additional elements integrates the judicial exception into a practical application. The claim recites no additional elements. It is further noted that isolated cells do not have markedly different characteristics due to their isolation. There is no indication in the specification that isolation of cells results in the any characteristics (structural, functional, or otherwise) that are different from the naturally occurring opsins in their natural state. As such the claimed composition does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception. (Step 2A prong 2: NO). Therefore, the claim is directed to a law of nature judicial exception.
The claim is then analyzed to see if it includes any additional features that could add significantly more to the exception. The claim does not integrate the naturally occurring product into any practical application. (Step 2B: NO), the claim does not qualify as eligible subject matter.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3, 6-7, 13-16, 18, 20, 22-23, 26 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lucas et al (EP3578197A1; Published Dec 11, 2019; hereinafter "Lucas;" See PTO-892) as evidenced by Dai et al (Sci China Life Sci. 2022 Jul; hereinafter “Dai;” See IDS 05/10/2024).
Regarding claims 1, 3, 6-7 and 13: Claim 6 of Lucas requires expression of a nucleic acid sequence which encodes a human photoreceptive protein is selected from the group consisting of human Rhodopsin or a photopsin in ON or OFF bipolar cells of retina. Further it is pointed out that [0033] of Lucas taught that the photosensitive protein can be a neuropsin or Opn5. It is noted that Lucas did not disclose coupling the cOpn5 as coupling to Gq as required by instant claims. However, as evidenced by Dai, it was discovered later in 2022 that chicken Opn5 couples to Gq (See Dai Abstract). It is noted that “the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” (See MPEP 2112). As such coupling to Gq was an inherent property of cOpn5 and was unappreciated prior to the filing date of the instant application. However, the newly discovered property does not render the claim novel under 35 U.S.C 102 as it was already inherently present in the molecule. As such the nucleic acid disclosed in Lucas inherently results in the production of the claimed opsin composition.
Regarding claims 14-16, 18 and 20: Claim 11 of Lucas disclosed a nucleic acid sequence which encodes a human photoreceptive protein is selected from the group consisting of human Rhodopsin or a photopsin. Further claim 14 of Lucas disclosed administration of the nucleic acid using viral vectors (instant claim 16, 18). Claim 2, requires use of a promoter for expression of the opsin. The promoter reads on the regulatory element as required by claim 15. It is noted that claim 1 of Lucas requires a photoreceptor, which reads on light-sensitive opsin. Further, [0033] of Lucas taught that the photosensitive protein can be a neuropsin or Opn5, which according to instant specification is coupled to Gq signaling (See instant specification [0072]).
Regarding claims 22, 23, and 26, 28: claim 14 of Lucas disclosed administration of a photopsin encoding nucleic acid using viral vectors for treatment of retinal degenerative diseases.
Claims 1, 4, 8 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamashita et al (Proc Natl Acad Sci U S A. 2010 Dec 21; hereinafter "Yamashita;" See IDS 05/10/2024) as evidenced by Dai et al (Sci China Life Sci. 2022 Jul; hereinafter “Dai;” See IDS 05/10/2024).
Regarding claim 1, 4, 8 and 12: Yamashita disclosed/characterized chicken opsin 5 proteins in retina of chicken and disclosed that “chicken Opn5 (cOpn5m) is a UV-sensitive bistable pigment that couples with Gi subtype of G protein. The recombinant expression of cOpn5m in HEK 293s cells followed by the addition of 11-cis- and all-trans-retinal produced UV light-absorbing and visible light-absorbing forms, respectively.” (See Yamashita Abstract). Yamashita further disclosed that “The absorption maxima of these forms were estimated to be 360 and 474 nm” (See Yamashita Abstract). It is noted that Yamashita did not disclose coupling the cOpn5 as coupling to Gq as required by instant claims. However, as evidenced by Dai, it was discovered later in 2022 that chicken Opn5 couples to Gq (See Dai Abstract). It is noted that “the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” (See MPEP 2112). As such coupling to Gq was an inherent property of cOpn5 and was unappreciated prior to the filing date of the instant application. However, the newly discovered property does not render the claim novel under 35 U.S.C 102 as it was already inherently present in the molecule.
Claim 1, 4 and 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tomonari et al (Dev Dyn. 2008 Jul; hereinafter "Tomonari;" See IDS 05/10/2024) as evidenced by Dai et al (Sci China Life Sci. 2022 Jul; hereinafter “Dai;” See IDS 05/10/2024).
Regarding claim 1, 4 and 10: Tomonari characterized the sequence of chicken opsin 5-related genes in the genome by a bioinformatic approach and isolated opsin 5 cDNA fragments from the embryonic retina by RT-PCR. (See Tomonari Abstract). Tomonari disclosed that “Three chicken nucleotide sequences encoding a protein similar to Opsin 5 were found as follows: NCBI gene name LOC421093 for nucleotide accession number XM_419178, LOC428670 or opsin 5 for XM_426228, and LOC422050 for XM_420056.” (See Tomonari, p. 1911, col. 1, para 3). XM_426228 of Tomonari is 100% identical to instant SEQ ID NO: 1 (See alignment below). As noted above, the Gq activating function of chicken Opn5 was discovered after the effective filing date of instant application, however, coupling to Gq was an inherent property of cOpn5 although it was not appreciated before the filing date.
Query 1 MSGMASDCNSSSQEEYLPHYVQQEDPFASKLSREADIIAGFYLTVIGILSTLGNGYVIFM 60
MSGMASDCNSSSQEEYLPHYVQQEDPFASKLSREADIIAGFYLTVIGILSTLGNGYVIFM
Sbjct 1 MSGMASDCNSSSQEEYLPHYVQQEDPFASKLSREADIIAGFYLTVIGILSTLGNGYVIFM 60
Query 61 SSKRKKKLRPAEIMTVNLAVCDLGISVVGKPFSIISFFSHRWIFGWMGCRWYGWAGFFFG 120
SSKRKKKLRPAEIMTVNLAVCDLGISVVGKPFSIISFFSHRWIFGWMGCRWYGWAGFFFG
Sbjct 61 SSKRKKKLRPAEIMTVNLAVCDLGISVVGKPFSIISFFSHRWIFGWMGCRWYGWAGFFFG 120
Query 121 CGSLITMTAVSLDRYLKICHLAYGTWLKRHHAFICLALIWAYATFWATVPFAGVGSYAPE 180
CGSLITMTAVSLDRYLKICHLAYGTWLKRHHAFICLALIWAYATFWATVPFAGVGSYAPE
Sbjct 121 CGSLITMTAVSLDRYLKICHLAYGTWLKRHHAFICLALIWAYATFWATVPFAGVGSYAPE 180
Query 181 PFGTSCTLDWWLAQASVAGQAFVLSILFFCLLFPTAVIVFSYVKIILKVKSSTKEVAHYD 240
PFGTSCTLDWWLAQASVAGQAFVLSILFFCLLFPTAVIVFSYVKIILKVKSSTKEVAHYD
Sbjct 181 PFGTSCTLDWWLAQASVAGQAFVLSILFFCLLFPTAVIVFSYVKIILKVKSSTKEVAHYD 240
Query 241 TRIQNSHILEMKLTKVAMLICAGFLIAWIPYAVVSVWSAFGQPDSVPIQFSVVPTLLAKS 300
TRIQNSHILEMKLTKVAMLICAGFLIAWIPYAVVSVWSAFGQPDSVPIQFSVVPTLLAKS
Sbjct 241 TRIQNSHILEMKLTKVAMLICAGFLIAWIPYAVVSVWSAFGQPDSVPIQFSVVPTLLAKS 300
Query 301 AAMYNPIIYQVIDCKFACCRSGGPKTLQKKSSLKESRMYTLSSHRDSAALSGTQLEV 357
AAMYNPIIYQVIDCKFACCRSGGPKTLQKKSSLKESRMYTLSSHRDSAALSGTQLEV
Sbjct 301 AAMYNPIIYQVIDCKFACCRSGGPKTLQKKSSLKESRMYTLSSHRDSAALSGTQLEV 357
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 1, 3-4, 6-16, 18, 20, 22, 23, 26, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15, 17,19, 21-22, and 25 of copending Application No. 18/709,383 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The following claims in the instant application are anticipated over the indicated claims in the reference application
Claims of Instant Application
Claims of reference Application (18/709,383)
1
1
3-4
1-4
6-13
5-12
14-16, 18
13-15, 17
20
19
22-23
21
26
21
28
25
Conclusion
Claims 9 and 11 appear free of art, but they are ineligible subject matter, lack written description and are indefinite.
No claim is allowed.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633
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